The patient received treatment on December 27, 2013 and has now returned home.
The trial is sponsored by Neuralstem's wholly-owned subsidiary, Neuralstem China, which was formed to develop Neuralstem's cell therapy products in China. The stroke motor deficit trial is the first in which Neuralstem's spinal-cord derived stem cells are being transplanted directly into the patient's brain.
They are placed near the stroke lesion, where it is hoped they will rebuild damaged neural circuitry and promote repair and recovery. The trial is expected to last two years.
"We are excited to begin the first trial where the route of administration for our cells is injection into the brain." said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer.
"We would like to thank our colleagues at BaYi, who are making this possible, and the patients who have volunteered for this ground-breaking trial. It is a crucial step forward for the company and the field at large, since optimizing cell therapy treatment for CNS indications will require delivering cells to the brain, as well as to the spinal cord. We are glad to be part of this world-leading clinical research project. BaYi Brain is a leading neurological medical institution in China with a state-of-the-art facility and advanced medical research and care staff. Through international collaborations, such as the clinical trial of neural stem cells for the treatment of ischemic stroke, we hope to be at the forefront of this new medical paradigm, treating multiple neurological diseases/disorders, such as ischemic stroke, spinal cord injury, ALS, and others, using the most advanced neural stem cells, developed by our U.S. partner, Neuralstem" said Professor Ruxiang Xu, Chief Physician, BaYi Brain Hospital.
It is estimated that over 1,750,000 people per year now survive a stroke, in China alone. Ischemic stroke occurs because of a loss of blood supply to part of the brain, initiating the ischemic cascade. Brain tissue ceases to function if deprived of oxygen for more than 60 to 90 seconds, and after approximately three hours will suffer irreversible injury possibly leading to death of the tissue, i.e., infarction. It accounts for 87% of all stroke cases, according to the American Stroke Association.
In the United States, stroke is the fourth-leading cause of death and a leading cause of adult disability, according to the National Stroke Association. Upwards of two-thirds of stroke survivors have some type of disability, according to the National Stroke Association. Post-stroke motor deficits include paralysis in arms and legs, and can be permanent.